FDA Recall D-0005-2022
RISING PHARMACEUTICALS · East Brunswick, NJ
Class II Ongoing 1715 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01
Reason for recall
Labeling: Incorrect Instructions
Recall record
- Recall number
D-0005-2022- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- to be entered
- Recall initiated
- 2021-09-02
- Classified by FDA Center
- 2021-10-07
- FDA published
- 2021-10-13
- Recalling firm
- RISING PHARMACEUTICALS
- Firm location
- East Brunswick, NJ
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.